MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DAVOL® FEMALE CATH KIT

Model Number	0035380
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the kit was missing the iodine swabs.
Event or Problem Description
It was reported that the kit was missing the iodine swabs.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿1.Open package and remove plastic wallet.2.Open plastic wallet and don gloves.3.Pull catheter out of tube to desired length.Lay tube in sterile field.4.Open lubricant and lubricate catheter.5.Open swab packet.Cleanse vaginal area.6.Proceed with catheterization.7.Pull catheter out of top; tighten cover and depress blue spout.8.Fill out label, place on centrifuge tube.Send to lab in normal manner.Important: 1.Use plastic wallet as sterile field.2.Pull catheter out of centrifuge tube to the proper length immediately after donning gloves.Note: if urine does not flow freely into the tube, the cap may need to be loosened slightly.".

• Brand Name: DAVOL® FEMALE CATH KIT
• Common Device Name: FEMALE CATH KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8367633
• Report Number: 1018233-2019-01020
• Device Sequence Number: 1253776
• Product Code: FFH
• UDI-Device Identifier: 00801741045820
• UDI-Public: (01)00801741045820
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 0035380
• Device Catalogue Number: 0035380
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1